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iSR'obot Kit - 13G

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref AS-00006416

by Biobot Surgical Pte Ltd

Identity

Trade Name
iSR'obot Kit - 13G EUDAMED
iSR'obot Kit FDA UDI
Generic Name
Needle guide, single-use FDA UDI
Device Name
iSR'obot Kit - 18G EUDAMED
Model / Reference
AS-00006416 EUDAMED
iSR'obot Kit - 13G FDA UDI

Identifiers

Catalog Number
AS-00006416 FDA UDI
Primary DI / UDI-DI
08885014610184 EUDAMEDFDA UDI
Basic UDI-DI
888501461iSRobotKit7V EUDAMED
510(k) Number
K232320 FDA UDI
FDA Product Code
OIJ FDA UDI
EMDN Code
Z12169085 VARIOUS INSTRUMENTS FOR UROLOGY - CONSUMABLES EUDAMED
GMDN Term
Needle guide, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

iSR'obot Kit - 13G by Biobot Surgical Pte. Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biobot Surgical Pte Ltd
EUDAMED SRN
SG-MF-000020631
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED c3249571-70ad-4e7b-9271-b1d0fa1bfb95 61 fields · synced Jul 15, 2026
  • FDA UDI e59d0791-e6dd-4a79-abee-f1a6124d26c2 34 fields · synced May 26, 2026